Extended AntiCoagulation Treatment for venous thromboembolism (VTE)

Not Applicable

Completed

• Conditions: Venous thromboembolism (VTE); Circulatory System; Pulmonary embolism

• Registration Number: ISRCTN73819751
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2013 protocol in http://www.ncbi.nlm.nih.gov/pubmed/23497371 2019 results in https://www.ncbi.nlm.nih.gov/pubmed/31891148 (added 02/01/2020) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32453520/ (added 05/03/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-09-13
• Study Completion: 2015-09-30
• Last Update Posted: 15 March 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 281

Inclusion Criteria

1. Aged 18 years or over, either sex
2. Diagnosis of first unprovoked proximal deep vein thrombosis (DVT) or pulmonary embolism (PE)
3. On treatment with anticoagulants
4. Have completed 3 - 6 months of anticoagulant therapy (target 2 - 3)

Exclusion Criteria

1. Patients under the age of 18 years
2. Patients with another indication for long term warfarin therapy, e.g., atrial fibrillation
3. Patients with a diagnosis of first unprovoked proximal DVT or PE who are no longer on anticoagulation therapy
4. Patients with a high risk of bleeding as evidenced by any of the following:
4.1. Patients with a previous episode of major bleeding where the cause was not effectively treated
4.2. Known thrombocytopaenia with a platelet count of less than 120 x 10^9 /L
4.3. Known chronic renal failure with a creatinine of more than 150 umols/L (1.7 mg/dl) or estimated glomerular filtration rate (eGFR) less than 30
4.4. Known chronic liver disease with a total bilirubin of more than 25 umols/L (1.5 mg/dl)
4.5. Active peptic ulcer
4.6. Poor compliance with, or control of, anticoagulation therapy during initial treatment (International Normalised Ratio [INR] control less than 50% time in range)
4.7. Patients requiring dual antiplatelet therapy (e.g., aspirin and clopidrogel)
5. Patients with a vena cava filter in place
6. Patients who have had a d?dimer test performed within 2 months of potential enrolment other than for evaluation for suspected recurrent VTE that was not confirmed
7. Patients whose GP expects their life expectancy to be less than 5 years
8. Patients unable to attend follow up visits due to geographic inaccessibility
9. Patients participating in a competing investigation
10. Patients with known antiphospholipid syndrome or known deficiency
11. Patients with a diagnosis of active cancer
12. Patients unwilling to give consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified